Sr. Manufacturing Engineer I

Description SetPoint Medical's Sr. Manufacturing Engineer will be responsible for leading and improving manufacturing processes across the product lifecycle, including development, technology transfer, and commercial production. In addition, the Sr. Manufacturing Engineer will identify and on-board 2nd source suppliers of our components and products as well as integrating next-generation platforms from the Product Development Department into manufacturing. This role works cross-functionally with Product Development, Operations, Quality, and external partners to ensure robust, scalable, and compliant manufacturing solutions. The Sr. Manufacturing Engineer plays a key part in the development and implementation of continuous improvement efforts within the organization. Requirements

• Scope and ownership of responsibilities will vary by level.
• Lead development, implementation, and optimization of manufacturing processes for medical device products
• Plan, execute, and document process validation activities (IQ/OQ/PQ) and equipment qualifications
• Support technology transfer from product development to manufacturing, including process scale-up and readiness
• Support all manufacturing qualification activities required for a FDA submission and approval of next generation products
• Identify and complete all deliverables needed for second sourcing our device components or the entire device itself (vendor NDA, scope of work, drawing reviews, characterization studies, validation/verification activities, first article complete, FDA approval) with minimal supervision
• Conduct root cause investigations and implement corrective and preventive actions (CAPA)
• Collaborate cross-functionally with Product Development, Quality, Operations, and external manufacturers
• Develop and maintain manufacturing documentation including work instructions, procedures, and specifications
• Identify and implement process improvements to enhance quality, efficiency, and cost-effectiveness
• Support QMS compliance through participation in NCR, CAPA, audits, and design control activities
• Provide technical leadership and mentorship to junior engineers and technicians
• Contribute to planning, prioritization, and execution of engineering projects and initiatives Leveling & Career Progression Level-specific expectations are defined in the Engineering Tiers and Career Progression Framework.

In general:

• Sr.

Manufacturing Engineer I:

Fully competent engineer; independently executes work and leads components of projects

• Sr.

Manufacturing Engineer II:

Advanced technical contributor; leads major workstreams, drives cross-functional initiatives, and influences technical direction Minimum Qualifications

• B.S. Degree in Mechanical, Electrical, Biomedical Engineering, or related field (advanced degree preferred)
• 7+ years of relevant experience, depending on level
• Experience in medical device manufacturing (Class II/III preferred)
• Strong knowledge of process validation, manufacturing systems, and regulatory requirements
• Experience with failure investigation tools and methodologies
• Familiarity with ISO 13485, GMP, and FDA regulations
• Experience working with contract manufacturers and cross-functional teams Skills & Abilities
• Strong technical problem-solving and analytical skills
• Ability to lead projects and influence cross-functional teams
• Strong communication skills (technical and non-technical)
• Ability to manage multiple priorities in a fast-paced environment
• Proficiency with manufacturing tools, equipment, and documentation systems
• Experience with CAD and/or data analysis tools preferred Physical Requirements
• Ability to sit at a desk and work on a computer for extended periods
• Ability to lift up to 15 pounds occasionally Work Location and Travel
• Company Headquarters in Valencia, CA
• Minimal travel opportunities may be available based on interest and business need Company Description SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.

Department:

Operations Reports To:

Sr.

Manager, Manufacturing Engineering FLSA Status:

Exempt Location:

Valencia, CA In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment. We are proud to be an equal opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.